# K934356: Wilson-Cook GI Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 7, 1994 after 122 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
69 later devices descend from it; 6 cite it directly.
1 of 70 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wilson-Cook Medical biopsy aspiration needles: named in the summary without a submission number

## Most influential descendants
- K083330: Echotip Ultra Ultrasound Needle (2009), 49 descendants of its own
- K100712: Resound Endoscopic Ultrasound Aspiration Needle (2010), 27 descendants of its own
- K110030: Expect Endoscopic Aspiration Needle (2011), 26 descendants of its own
- K112198: Expect Endoscopic Ultrasound Aspiration Needle (2011), 16 descendants of its own
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), 16 descendants of its own

## Indications for use
to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.

Source page: https://510kreport.com/device/K934356
Methodology: https://510kreport.com/methodology